Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amakem, NV
ClinicalTrials.gov Identifier:
NCT01693315
First received: September 21, 2012
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

The objective of this dose-escalation study is to evaluate the safety, tolerability and efficacy of AMA0076 in reduction of intraocular pressure in subjects with ocular hypertension or primary open-angle glaucoma.


Condition Intervention Phase
Glaucoma
Ocular Hypertension
Eye Disease
Drug: AMA0076
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Double-masked, Placebo-controlled, Dose-escalation Study of AMA0076 in Topical Ocular Formulation for Safety, Tolerability and Efficacy in Reduction of Intraocular Pressure in Subjects With Ocular Hypertension or Primary Open-angle Glaucoma

Resource links provided by NLM:


Further study details as provided by Amakem, NV:

Primary Outcome Measures:
  • intraocular pressure change from baseline. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events as a measure of safety/tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • IOP assessments at weekly visits [ Time Frame: Weeks 1, 2, 3, 4 ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: September 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 - AMA0076 Dose A (or vehicle)
Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (12 active : 3 placebo).
Drug: AMA0076 Drug: Placebo
Experimental: Cohort 2: AMA0076 Dose B (or vehicle)
Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (12 active : 3 placebo).
Drug: AMA0076 Drug: Placebo
Experimental: Cohort 3: AMA0076 Dose C (or vehicle)
Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (20 active : 5 placebo).
Drug: AMA0076 Drug: Placebo
Experimental: Cohort 4: AMA0076 Dose D (or vehicle)
Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (20 active : 5 placebo).
Drug: AMA0076 Drug: Placebo

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria include:

  1. Adults 30-85 years of age
  2. Diagnosis of either ocular hypertension or primary open-angle glaucoma in both eyes
  3. Not receiving medication for IOP, or able to stop such medication for a washout period and the duration of the study without significant risk of adverse consequences related to glaucomatous disease
  4. Elevated IOP (≥ 24 and ≤ 34 mm Hg at 8 AM and ≥ 21 and ≤ 34 mm Hg at 10 AM on Screening Two visit and Baseline visit in one or both eyes off treatment

Exclusion Criteria include:

  1. Uncontrolled intraocular hypertension defined as >34 mm Hg at either of the screening/baseline visits (after a washout phase in those subjects who were currently receiving ocular hypotensive therapy).
  2. Receiving more than one medication for IOP at time of screening.
  3. Central corneal thickness of less than 500 µm or greater than 620 µm.
  4. BCVA worse than 20/200 in either eye
  5. Significant visual field loss (ie, mean deviation > 10 db or field loss within 10 degrees of fixation), a new field defect, or progression of an existing field defect in either eye during the year preceding the study.
  6. Acute angle-closure glaucoma or appositional or very narrow anterior chamber angle in either eye.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693315

Locations
United States, California
Artesia Clinical Site - Site 02
Artesia, California, United States
Inglewood Clinical Site - Site 03
Inglewood, California, United States
Petaluma Clinical Site - Site 05
Petaluma, California, United States
United States, Connecticut
New Haven Clinical Site - Site 01
New Haven, Connecticut, United States
United States, Georgia
Atlanta Clinical Site - Site 04
Atlanta, Georgia, United States
United States, North Carolina
High Point Clinical Site - Site 06
High Point, North Carolina, United States
Sponsors and Collaborators
Amakem, NV
  More Information

No publications provided

Responsible Party: Amakem, NV
ClinicalTrials.gov Identifier: NCT01693315     History of Changes
Other Study ID Numbers: AMA0076-201
Study First Received: September 21, 2012
Last Updated: July 16, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Eye Diseases
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014